San Ramon, Calif., and Mainz, Germany, April 17, 2017 — BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced the first image fusion-guided procedure with its Revivent TC system. The procedure, known as Less Invasive Ventricular Enhancement™ or LIVE™, was performed at the Heart Center of the Universitätsmedizin Mainz, a branch of Johannes Gutenberg-University in Mainz, Germany. The senior interventional cardiologists were Ralph Stephan von Bardeleben, MD and Eberhard Schulz, MD. The cardiothoracic surgeon was Walter Kasper-König, MD.
The device was successfully implanted with two micro-anchor pairs in a 53-year- old female patient suffering from NYHA class III ischemic heart failure. The patient underwent a multi-phase and multi-slice diagnostic Computed Tomography (CT) scan in advance of the procedure. The CT scan demonstrated the scar distribution and enhanced the accurate pre-operative determination of anchor implant location. During the procedure, the pre-acquired CT scan was registered and fused with Fluoroscopy using HeartNavigator 3.0, a new cath lab fusion software (Philips Healthcare, Best, The Netherlands). This facilitated the real-time, intra-operative navigation of BioVentrix devices and resulted in a very positive clinical outcome for the patient.
The physicians achieved a 20% increase in Ejection Fraction (EF) and a 30% reduction in Left Ventricular Volume. By remodeling the LV to a more normal shape and size, the implant improves pumping efficiency, decreases wall stress, and immediately reverses the patient’s symptoms. “We are very excited to be the first center to perform the Revivent TC procedure with image fusion-guidance. The Revivent TC system, in combination with imaging modalities such as CT and Fluoroscopy, led to a very positive clinical outcome for the patient,” said Dr. von Bardeleben. “We are pleased with the results and look forward to our continued partnership with BioVentrix to offer this therapy to our patients,” continued Dr. von Bardeleben.
“By decreasing the excessive volume via a very small incision in the lateral chest wall, without the use of cardiopulmonary bypass and with a beating heart, more patients will have the opportunity to benefit from this therapy. We are very impressed with the clinical benefits of the Revivent TC system,” added Dr. Kasper-König.
About BioVentrix and the Revivent TC System
BioVentrix, a privately held medical technology company headquartered in San Ramon, Calif., is focused on developing and commercializing minimally invasive therapies for treating HF. The company recently received CE mark certification for its closed-chest Revivent TC TransCatheter Ventricular Enhancement System for plication of scar tissue in post-MI, ischemic cardiomyopathy patients. Placement of the Revivent TC System via the LIVE procedure obviates the need for more invasive surgery. Instead, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a catheter-based approach. The anchors are then pulled towards one another, effectively excluding the scarred and non-functioning heart wall. Ventricular volume is immediately reduced as a result of the exclusion, by as much as 30-40 percent 1.
Note: The Revivent TC System is approved for sale in Europe; it is not approved for sale in the United States.
- Wechsler, A. et al., Clinical benefits twelve months after less invasive ventricular restoration operations without ventriculotomy. Annual meeting of the European Society of Cardio-Thoracic Surgery, 07 Oct. 2013, Vienna, Austria.
